Research is often conducted without the knowledge or consent of those whose tissues are banked and poses possible harms to social groups if information about a few members is unscientifically applied to all.
The FDA’s expanded access pathway allows patients with no other therapeutic options to request access to investigational agents, but manufacturers do not often grant it.
AMA J Ethics. 2015;17(12):1142-1146. doi:
10.1001/journalofethics.2015.17.12.stas1-1512.
Clinical equipoise—the idea that the community of medical experts is uncertain about the relative therapeutic merits of the arms of a clinical trial at its outset—mitigates physicians’ responsibility for patients’ poor outcomes when patients are assigned to the control arm or are harmed by an investigational agent.
AMA J Ethics. 2015;17(12):1108-1115. doi:
10.1001/journalofethics.2015.17.12.ecas1-1512.
Erin P. Williams, MBE and Jennifer K. Walter, MD, PhD, MS
Undue influence, which occurs when prospective research participants who otherwise would not enroll are induced to enter studies that might pose significant risks, may also involve social injustices such as unequal payment and participant selection methods that unequally distribute the potential harms and benefits of research.
AMA J Ethics. 2015;17(12):1116-1121. doi:
10.1001/journalofethics.2015.17.12.ecas2-1512.